In response to the 2022 Monkeypox outbreak in non-endemic regions, Coris BioConcept, in partnership with INMI, initiated the development of a point-of-care (POC) LAMP assay aimed at rapidly detecting the Monkeypox virus in human samples. This scientific project addresses the critical need for swift diagnostics to manage and limit human-to-human transmission of the virus.
Throughout the assay development, the ISIDORe project provided essential support by supplying viral DNA and granting access to high-containement laboratory facilities for rigorous validation of the prototypes.
A first version of Mpox LAMP assay was designed with specific primers targeting the West African and Congo Basin clades, combined with an optimized reaction mix, which was stabilized in PCR microtubes through a drying method. The assay’s performance was first evaluated using synthetic DNA, followed by tests with viral DNA extracted from virus cultures provided by INMI. Further testing were then performed at INMI using DNA extracted from clinical samples, including throat swabs and skin lesions. The dried LAMP assay demonstrated a detection limit of 300 copies of viral DNA per reaction, with 96% of clinical samples, confirmed positive by qPCR with Ct values below 32, being detected as positive within 30 minutes.
This dried LAMP assay developed by Coris BioConcept, with ISIDORe and INMI’s support, offers performance comparable to qPCR, marking a significant advancement toward a rapid and sensitive diagnostic test for direct use in the POC. Current efforts are focused on increasing the assay’s sensitivity by incorporating a second targeted gene and developing a simplified extraction protocol.